Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study

Launched by XELTIS · Mar 22, 2024

Keywords

ClinConnect Summary

The aXess-E Study is a clinical trial that is looking at a new device called the Xeltis Hemodialysis Access conduit. This study is for adults over 18 years old who have end-stage renal disease (ESRD) and need to start or continue hemodialysis, a treatment that helps people with kidney failure. The main goal of the trial is to see if this new device is safe and works well for helping patients with their dialysis needs.

To be eligible for the study, participants must have a suitable vein for placing the conduit and agree to follow-up appointments both before and after the procedure. However, some individuals may not qualify, such as those with severe heart disease, uncontrolled diabetes, or certain infections. If someone joins the study, they can expect regular check-ins to monitor their health and the performance of the device over time. Overall, this study aims to improve hemodialysis access and make treatment easier and safer for patients with kidney issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects with end-stage renal disease (ESRD) who require placement of an Arteriovenous Graft (AVG) in the upper extremity to start or maintain hemodialysis therapy
• • 2. At least 18 years of age at screening
• • 3. Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess-E conduit
• • 4. The patient has been informed about the nature of the study, understands and agrees to its provisions, and has personally provided written informed consent
• • 5. The patient has been informed and agrees to pre- and post- procedure follow-up
• • 6. Life expectancy of at least 12 months
• Exclusion Criteria:
• • 1. History or evidence of severe cardiac disease (New York Heart Association (NYHA) Functional Class IV and/or Ejection Fraction (EF) \<25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
• • 2. Uncontrolled or poorly controlled diabetes
• • 3. Abnormal blood values that could influence patient recovery and or/ conduit hemostasis
• • 4. Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \>1.5 or prothrombin time (PT) \>18 seconds
• • 5. Any active local or systemic infection
• • 6. Known heparin-induced thrombocytopenia
• • 7. Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
• • 8. Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
• • 9. Anticipated renal transplant within 6 months
• • 10. Known or suspected central vein obstruction on the side of planned conduit implantation
• • 11. Previous dialysis access conduit in the operative limb unless the aXess-E conduit can be placed more proximally than the previous failed conduit
• • 12. Previous enrolment in this study
• • 13. Subject is participating in another study
• • 14. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
• • 15. Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit
• Intra-operative exclusion criteria:
• • 1. Unsuitable anatomy to implant the aXess-E conduit (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)